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Initiative at Dartmouth

CIRRICULUM
WEEK 2:  REGULATORY 101 

DAY 1

Arrive in the DC Area (late afternoon)

Group Dinner (early evening)

 DAY 2

(Day at the FDA)

Meet and Greet, Introductions

     Bram Zuckerman, MD, Office Director
     Office of Health Technology 2, Cardiovascular Devices

     Andrew Farb, MD, Chief Medical Officer

     Office of Product Evaluation and Quality                       Cardiovascular Devices     

 

FDA Device Policy

     Historical Perspective

     

Regulatory Pathways (overview)
     510K, De Novo, PMA

 

Preclinical Considerations

     Animal Studies & Engineering

Clinical Studies

     Clinical Trial Design

Evidence Evaluation

     Statistical Concerns

Post-Market Considerations

     Daniel Canos, PhD, Office Director

     Office of Clinical Evidence and Analysis

     Office of Product Evaluation & Quality    

 

Lunch Roundtable

     Reviewers, Statisticians & Engineers

Case Study

     Emily Zeitler, MD, MHS, Co-Director 3D Initiative

     Associate Professor of Medicine 
     
Geisel School of Medicine at Dartmouth

     Aaron Kaplan, MD, FACC, Co-Director 3D Initiative

     Professor of Medicine
     
Geisel School of Medicine at Dartmouth

 

Observation of FDA Meetings

 

Group Dinner

 DAY 3 

(1/2 Day at CMS)

Meet and Greet, Introductions

     Steve Farmer, MD, FACC, FASE, 

     Chief Strategy Officer for Coverage, CMS

 

CMS Authority and Bene Categories

     Historical Perspective

                 

Local vs National Coverage

 

Coverage with Evidence Development

     TCET & Other Emerging Policies

     Steve Farmer, MD, FACC, FASE

     Chief Strategy Officer for Coverage, CMS

 

Clinical Studies

     Clinical Trial Design

 

Evidence Evaluation

     Statistical Concerns

 

Post-Market Considerations

     Daniel Canos, PhD, Office Director

     Office of Clinical Evidence and Analysis

     Office of Product Evaluation & Quality    

 

Roundtable

     Reviewers, Statisticians & Engineers

 

Case Study

     Emily Zeitler, MD, MHS, Co-Director 3D Initiative

     Associate Professor of Medicine,

     Geisel School of Medicine at Dartmouth

     

     Aaron Kaplan, MD, FACC, Co-Director 3D Initiative

     Professor of Medicine

     Geisel School of Medicine at Dartmouth

(1/2 Day)

Consulting and Law Firms

     Role of the Consulting Firm

     Case Study

Group Dinner

DAY 4

Working Breakfast

     Debrief

     Homework

     Planning and Goal Setting

 

Depart

Week 2 LOGISTICS

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